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Registri di patologia

  • Emanuele Crocetti1

  1. UO Epidemiologia clinica e descrittiva, ISPO Firenze
Emanuele Crocetti -

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Ricerca bibliografica periodo dal 16 marzo 2012 al 31 maggio 2012

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Stringa: (("registries"[MeSH Terms] OR "registries"[All Fields] OR "registry"[All Fields]) OR ("registries"[MeSH Terms] OR "registries"[All Fields])) AND (("italy"[MeSH Terms] OR "italy"[All Fields]) OR italian[All Fields]) AND "humans"[MeSH Terms] AND ("2012/03/16"[PDat] : "2012/05/31"[PDat])
1. Dorigo W, Pulli R, Piffaretti G, Castelli P, Griselli F, Dorrucci V, Ferilli F, Ottavi P, De Blasis G, Scalisi L, Monaca V, Battaglia G, Vecchiati E, Casali G, Pratesi C. Results from an Italian multicentric registry comparing heparin-bonded ePTFE graft and autologous saphenous vein in below-knee femoro-popliteal bypasses. J Cardiovasc Surg (Torino). 2012 Apr;53(2):187-94.
Department of Vascular Surgery, University of Florence, Florence, Italy. dorigow@unifi.it

Abstract
AIM: The aim of this study was to evaluate early and follow-up results of below-knee bypasses performed with a bioactive heparin-treated ePTFE graft in patients with peripheral arterial obstructive disease (PAOD) in a multicentric retrospective registry involving seven Italian vascular centers and to compare them with those obtained in patients operated on with autologous saphenous vein (ASV) in the same centres in the same period of time.
METHODS: Over a nine-year period, ending in 2010, a heparin bonded prosthetic graft (Propaten Gore-Tex, W.L. Gore & Associates Inc, Flagstaff, AZ, USA) was implanted in 556 patients undergoing below-knee revascularization for PAOD (HePTFE group). In the same period of time 394 below-knee bypasses with ipsilateral ASV were performed (ASV group). Data concerning these interventions were retrospectively collected in a multicenter registry with a dedicated database. Early (<30 days) results were analyzed in terms of graft patency, major amputation rates and mortality. Follow-up results were analyzed in terms of primary and secondary graft patency, limb salvage and survival.
RESULTS: Among patients of HePTFE group, 413 had critical limb ischemia (74%); the corresponding figure for ASV group was 84% (332 interventions, P<0.001). Eighty-nine patients in HePTFE group (16%) and 207 patients in ASV group (52.5%; P<0.001) had distal tibial anastomosis. Patients in HePTFE group had more frequently adjunctive procedures performed at distal anastomotic sites in order to improve run-off status. Thirty-day death rate was 1.9% in HePTFE group and 0.5% in ASV group (P=0.08). The rates of perioperative thromboses and amputations were 6% and 3.5% in HePTFE group, and 5% and 1.7% in ASV group, without significant differences between the two groups. Mean duration of follow-up was 28.5±22.1 months; 921 patients (97%) had at least one postoperative clinical and ultrasonographic control. Estimated 48-month survival rates were 81% in HePTFE group and 74% in ASV group (P=0.7, log rank 0.1). Primary patency rate at 48 months was significantly better in ASV group (61%) than in HePTFE group (44.5%; P=0.004, log rank 8.1). The rates of secondary patency at 48 months were 57% in HePTFE group and 67.5% in ASV group (P=0.1, log rank 1.9); the corresponding values in terms of limb salvage in patients with critical limb ischemia were 77% and 79.5% (P=0.3, log rank 0.9), respectively.
CONCLUSION: Data from this large, retrospective registry confirmed that the indexed heparin-bonded ePTFE graft provides satisfactory early and mid-term results in patients undergoing surgical below-knee revascularization. While autologous saphenous vein maintains its superiority in terms of primary patency, secondary patency and limb salvage rates are comparable.

2. Trimarchi S, Tolenaar JL, Tsai TT, Froehlich J, Pegorer M, Upchurch GR, Fattori R, Sundt TM 3rd, Isselbacher EM, Nienaber CA, Rampoldi V, Eagle KA. Influence of clinical presentation on the outcome of acute B aortic dissection: evidences from IRAD. J Cardiovasc Surg (Torino). 2012 Apr;53(2):161-8.
Thoracic Aortic Research Center, Policlinico San Donato IRCCS, University of Milan, Milan, Italy. santi.trimarchi@unimi.it

Abstract
AIM: In-hospital outcome of acute type B dissection (ABAD) is strongly related to preoperative aortic conditions. In order to clarify the influence of the clinical presentation on the outcome, we analyzed the patients of the International Registry of Acute Aortic Dissection (IRAD). All patients affected by complicated ABAD, enrolled in the IRAD from 1996-2004, were included. Complications were defined as the presence of shock, periaortic hematoma, spinal cord ischemia, preoperative mesenteric ischemia/infarction, acute renal failure, limb ischemia, recurrent pain, refractory pain or refractory hypertension (group I). All other patients were categorized as uncomplicated (group II). A comprehensive analysis was performed of all clinical variables in relation to in-hospital outcome.
RESULTS: The overall in-hospital mortality among 550 patients was 12.4%. Mortality in group I (250 patients) was 20.0 %, compared to 6.1% in group II (300 patients) (P<0.001). Univariate predictors of ABAD complications were Marfan syndrome, abrupt onset of pain, migrating pain, any focal neurological deficits, need for higher number of diagnostic examinations and use of magnetic resonance and/or aortogram, abdominal vessels involvement at aortogram, larger descending aortic diameter, especially >6 cm, pleural effusion, and widened mediastinum on chest X-ray. Univariate predictors of a non complicated status were normal chest X-ray and medical management. In group I, in-hospital mortality following surgical and endovascular intervention were 28.6% and 10.1% (P=0.006), respectively. Independent predictors of overall in-hospital mortality included age >70 years, female gender, ECG showing ischemia, preoperative acute renal failure, preoperative limb ischemia, periaortic hematoma, and surgical management. The only independent variable protective for mortality was magnetic resonance as diagnostic test.
CONCLUSION: ABAD is a heterogeneous disease that produces dissimilar clinical subsets, each of which can have specific clinical signs, management and in-hospital results. In IRAD ABAD uncomplicated patients, medical therapy was associated with best hospital outcome, while endovascular interventions were associated with better results than surgery when invasive treatments were required. Although selection bias may be possible, and irrespective of treatments, knowledge of significant risk factors for mortality may contribute to a better management and a more defined risk-assessment in patients affected by ABAD.

3. Toni D, Ahmed N, Anzini A, Lorenzano S, Brozman M, Kaste M, Mikulik R, Putaala J, Wahlgren N; SITS investigators. Intravenous thrombolysis in young stroke patients: results from the SITS-ISTR. Neurology. 2012 Mar 20;78(12):880-7. Epub 2012 Mar 7.
Department of Neurology and Psychiatry, La Sapienza University of Rome, Italy. danilo.toni@uniroma1.it

Abstract
OBJECTIVE: To assess safety and efficacy of thrombolysis in 18- to 50-year-old patients compared to those aged 51 to 80 years recorded in the Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register (SITS-ISTR).
METHODS: A total of 27,671 patients aged 18-80 years treated with IV alteplase within 4.5 hours of symptom onset were enrolled in SITS-ISTR between 2002 and 2010. Main outcome measures were symptomatic intracerebral hemorrhage (SICH; deterioration of ≥4 points on the NIH Stroke Scale [NIHSS] within 24 hours and type 2 parenchymal hematoma), mortality, and functional independence (modified Rankin Scale [mRS] 0-2) at 3 months.
RESULTS: In the 3,246 (11.7%) patients aged 18-50, SICH occurred in 0.6% vs 1.9% in those aged 51-80 (adjusted odds ratio [aOR] 0.53; 95% confidence interval [CI] 0.31-0.90, p = 0.02). Three-month mortality was 4.9% and 14.4%, respectively (aOR 0.49; 95% CI 0.40-0.60, p < 0.001) and functional independence was 72.1% vs 54.5%, respectively (aOR 1.61; 95% CI 1.43-1.80, p < 0.0001). In multivariable analysis in young patients, baseline systolic blood pressure (SBP) was the only independent factor associated with SICH (p = 0.04). Baseline NIHSS, baseline glucose, and signs of infarction in baseline imaging scan were associated with higher mortality and poorer functional outcome. Male gender, mRS before stroke, and atrial fibrillation (AF) were associated with higher mortality, and age, SBP, and previous stroke were associated with mRS.
CONCLUSIONS: Treatment with IV alteplase is safe in young ischemic stroke patients and they benefit more compared to older patients. We found several factors associated with SICH, mortality, and functional outcome. These can be used to help in the selection of young ischemic stroke patients for thrombolysis. Classification of evidence: This study provides Class III evidence that younger patients (18-50 years) with ischemic stroke symptoms treated with IV alteplase have lower morbidity and mortality compared to older patients (51-80 years).

4. Passariello A, Terrin G, Cecere G, Micillo M, De Marco G, Di Costanzo M, Cosenza L, Leone L, Nocerino R, Canani RB. Randomised clinical trial: efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060 plus arabinogalactan and xilooligosaccharides in children with acute diarrhoea. Aliment Pharmacol Ther. 2012 Apr;35(7):782-8. doi: 10.1111/j.1365-2036.2012.05015.x. Epub 2012 Feb 13.
Department of Paediatrics, University of Naples "Federico II", Italy.

Abstract
BACKGROUND: Acute diarrhoea is a frequent problem in children with heavy economic burden for families and society. AIM: To test the efficacy of a new synbiotic formulation containing Lactobacillus paracasei B21060, arabinogalactan and xilooligosaccharides in children with acute diarrhoea.
METHODS: Double-blind, randomised, placebo-controlled trial, including children (age 3-36 m) with acute diarrhoea who were allocated to placebo or synbiotic group. Major outcome was resolution rate of diarrhoea at 72 h. Total duration of diarrhoea, daily stool outputs, stool consistency, working days lost by parents, adjunctive medications, and hospitalisation were also assessed.
RESULTS: We enrolled 55 children in placebo group and 52 in synbiotic group. The two groups were similar for demographic and clinical characteristics. Resolution rate of diarrhoea at 72 h was significantly higher in synbiotic group (67%) compared to placebo group (40%, P = 0.005). Children in synbiotic group showed a significant reduction in the duration of diarrhoea (90.5 h, 78.1-102.9 vs. 109.8 h, 96.0-123.5, P = 0.040), daily stool outputs (3.3, 2.8-3.8 vs. 2.4, 1.9-2.8, P = 0.005) and stool consistency (1.3, 0.9-1.6 vs. 0.6, 0.4-0.9, P = 0.002) compared to placebo group (data expressed as mean, 95% CI). Rate of parents that missed at least one working day (41.8% vs. 15.4%, P = 0.003), rate of children that needed adjunctive medications (25.5% vs. 5.8%, P = 0.005) or hospitalisation (10.9% vs. 0%, P = 0.014) after the first 72 h of treatment, were reduced in synbiotic group.
CONCLUSION: The synbiotic formulation studied is effective in children with acute diarrhoea. Australian New Zealand Clinical Trials Registry (ACTRN12611000641998).

5. Pagano L, Caira M, Rossi G, Tumbarello M, Fanci R, Garzia MG, Vianelli N, Filardi N, De Fabritiis P, Beltrame A, Musso M, Piccin A, Cuneo A, Cattaneo C, Aloisi T, Riva M, Rossi G, Salvadori U, Brugiatelli M, Sannicolò S, Morselli M, Bonini A, Viale P, Nosari A, Aversa F; Hema e-Chart Group, Italy. A prospective survey of febrile events in hematological malignancies. Ann Hematol. 2012 May;91(5):767-74. Epub 2011 Nov 29.
Istituto di Ematologia, Università Cattolica del Sacro Cuore, Largo Francesco Vito, 1, I-00168 Roma, Italy. lpagano@rm.unicatt.it

Abstract The Hema e-Chart prospectively collected data on febrile events (FEs) in hematological malignancy patients (HMs). The aim of the study was to assess the number, causes and outcome of HM-related FEs. Data were collected in a computerized registry that systematically approached the study and the evolution of FEs developing in a cohort of adult HMs who were admitted to 19 hematology departments in Italy from March 2007 to December 2008. A total of 869 FEs in 3,197 patients with newly diagnosed HMs were recorded. Fever of unidentified origin (FUO) was observed in 386 cases (44.4%). The other causes of FE were identified as noninfectious in 48 cases (5.5%) and infectious in 435 cases (50.1%). Bacteria were the most common cause of infectious FEs (301 cases), followed by fungi (95 cases), and viruses (7 cases). Mixed agents were isolated in 32 episodes. The attributable mortality rate was 6.7% (58 FEs). No deaths were observed in viral infection or in the noninfectious groups, while 25 deaths were due to FUO, 16 to bacterial infections, 14 to fungal infections, and three to mixed infections. The Hema e-Chart provided a complete system for the epidemiological study of infectious complications in HMs. PMID: 22124621 [PubMed - indexed for MEDLINE]

6. Mallone S, De Vries E, Guzzo M, Midena E, Verne J, Coebergh JW, Marcos-Gragera R, Ardanaz E, Martinez R, Chirlaque MD, Navarro C, Virgili G; RARECARE WG. Descriptive epidemiology of malignant mucosal and uveal melanomas and adnexal skin carcinomas in Europe. Eur J Cancer. 2012 May;48(8):1167-75. Epub 2011 Nov 25.
Collaborators: Zielonk N, Van Eycken E, Sundseth H, Hedelin G, Woronoff AS, Buemi A, Tretarre B, Colonna M, Bara S, Ganry O, Grosclaude P, Holleczek B, Geissler J, Tryggvadottir L, Deady S, Bellú F, Ferretti S, Serraino D, Vercelli M, Vitarelli S, Federico M, Fusco M, Michiara M, Giacomin A, Tumino R, Mangone L, Falcini F, Senatore G, Budroni M, Piffer S, Crocetti E, La Rosa F, Contiero P, Zambon P, Casali PG, Gatta G, Gronchi A, Licitra L, Ruzza M, Sowe S, Trama A, Capocaccia R, De Angelis R, Tavilla A, Dei Tos AP, England K, Ursin G, Rachtan J, Gozdz S, Zwierko M, Bielska-Lasota M, Slowinski J, Miranda A, Safaei Diba Ch, Primic-Zakelj M, Mateos A, Izarzugaza I, Torrella-Ramos A, Galceran J, Martinez-Garcia C, Perez MJ, Melchor JM, Cervantes A, Adolfsson J, Lambe M, Möller TR, Ringborg U, Jundt G, Usel M, Ess SM, Spitale A, Konzelmann I, Lutz JM, Visser O, Otter R, Siesling S, van der Zwan JM, Schouten H, Greenberg DC, Wilkinson J, Roche M, Meechan D, Lawrence G, Coleman MP, Mackay J, Gavin A, Brewster DH, Black RJ, Kunkler I, White C.

Cancer Epidemiology Unit, National Center for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Viale Regina Elena 299, Rome, Italy. sandra.mallone@iss.it

Abstract This work provides descriptive epidemiological data of malignant mucosal and uveal melanomas and adnexal skin carcinomas in Europe as defined as in the RARECARE project. We analysed 8669 incident cases registered in the period 1995-2002 by 76 population-based cancer registries (CRs), and followed up for vital status to 31st December 2003. Age-standardised incidence to the European standard population was obtained restricting the analysis to 8416 cancer cases collected by 64 not specialised CRs or with information available only for some anatomical sites. Period survival rates at 2000-2002 were estimated on 45 CRs data. Twenty-two CRs which covered the period 1988-2002 were analysed to obtain the 15-year prevalence (1st January 2003 as reference date). Complete prevalence was calculated by using the completeness index method which estimates surviving cases diagnosed prior to 1988 ('unobserved' prevalence). The expected number of new cases per year and of prevalent cases in Europe was then obtained multiplying the crude incidence and complete prevalence rates to the European population at 2008. We estimated 5204 new cases per year (10.5 per million) to occur in Europe, of which 48.7% were melanomas of uvea, 24.8% melanomas of mucosa and 26.5% adnexal carcinomas of the skin. Five-year relative survival was 40.6% and 68.9% for mucosal and uveal melanomas, respectively. Adnexal skin carcinomas showed a good prognosis with a survival of 87.7% 5 years after diagnosis. Northern Europe, United Kingdom (UK) and Ireland showed the highest 5-year survival rate for uveal melanomas (72.6% and 73.4%), while Southern Europe showed the lowest rate (63.7%). More than 50,000 persons with a past diagnosis of one of these rare cancers were estimated to be alive at 2008 in Europe, most of them (58.8%, n=29,676) being patients with uveal melanoma. Due to the good prognosis and high incidence of uveal melanomas, these malignancies are highly represented among the long-term survivors of the studied rare cancer types. Therefore, maximising quality of life is particularly important in treatment of uveal melanoma. As regards mucosal melanomas, the centralisation of treatment to a select number of specialist centres as well as the establishment of expert pathology panels should be promoted. The geographical differences in incidence and survival should be further investigated analysing the centre of treatment, the stage at diagnosis and the treatment.

Breve commento a cura di E. Crocetti
Si tratta di uno studio basato sui dati di un ampio numero di Registri Tumori di popolazione europei che rientra nel progetto Rarecare. Rarecare (www.rarecare.eu) è un progetto orientato alla stima dei più importanti indicatori epidemiologici (incidenza, sopravvivenza, prevalenza e mortalità) dei tumori rari che ha proposto una loro definizione quantitativa basata su una frequenza di diagnosi (incidenza) inferiore a 6 casi ogni 100000 soggetti/anno. Questa definizione ha portato alla creazione di una lista di tumori rari indicati da coppie topografia/morfologia della terza versione della Classificazione internazionale delle malattie per l’oncologia (ICDO-3). Tra i tumori rari rientrano quelli analizzati in questo studio ovvero i melanomi delle mucose, quelli dell’uvea (relativamente più frequenti degli altri) e i carcinomi degli annessi cutanei. Nell’articolo vengono fornite le stime di frequenza (circa 2550 casi/anno di melanomi uveali e circa 1300 per ciascuno degli altri due gruppi), sopravvivenza (buona per i carcinomi degli annessi, media per i melanomi uveali e peggiore per quelli delle mucose) e prevalenza per questo gruppo eterogeneo di tumori, per sesso, età ed aree geografiche europee. Alcune differenze geografiche sollevano il dubbio che la completezza nella diagnosi e nella rilevazione non sia omogenea nelle varie aree geografiche europee (ad esempio nell’est Europa l’incidenza dei melanomi delle mucose è molto bassa). Nel caso di eventi come questi, che si misurano in termini di singole unità per milione di abitanti/anno, i comuni indici di qualità e completezza – che nello studio sono generalmente accettabili – possono non essere adeguati ad affermare la confrontabilità delle casistiche.

7. Guglielmini P, Rubagotti A, Boccardo F. Serum enterolactone levels and mortality outcome in women with early breast cancer: a retrospective cohort study. Breast Cancer Res Treat. 2012 Apr;132(2):661-8. Epub 2011 Nov 18.
Department of Oncology, Biology and Genetics, University of Genoa, Genoa, Italy.

Abstract We previously demonstrated that high serum enterolactone levels are associated with a reduced incidence of breast cancer in healthy women. The present study was aimed at investigating whether a similar association might be found between serum enterolactone levels and the mortality of women with early breast cancer. The levels of enterolactone in cryopreserved serum aliquots obtained from 300 patients, operated on for breast cancer, were measured using a time-resolved fluoro-immunoassay. Levels were analyzed in respect to the risk of mortality following surgery. Cox proportional hazard regression models were used to check for prognostic features, to estimate hazard ratios for group comparisons and to test for the interaction on mortality hazards between the variables and enterolactone concentrations. The Fine and Gray competing risk proportional hazard regression model was used to predict the probabilities of breast cancer-related and breast cancer-unrelated mortalities. At a median follow-up time of 23 years (range 0.6-26.1), 180 patients died, 112 of whom died due to breast cancer-related events. An association between a decreased mortality risk and enterolactone levels ≥ 10 nmol/l was found in respect to both all-cause and breast cancer-specific mortality. The difference in mortality hazards was statistically significant, but it appeared to decrease and to lose significance after the first 10 years, though competing risk analysis showed that breast cancer-related mortality risk remained constantly lower in those patients with higher enterolactone levels. Our findings are consistent with those of most recent literature and provide further evidence that mammalian lignans might play an important role in reducing all-cause and cancer-specific mortality of the patients operated on for breast cancer.

8. Pratali L, Rimoldi SF, Rexhaj E, Hutter D, Faita F, Salmòn CS, Villena M, Sicari R, Picano E, Allemann Y, Scherrer U, Sartori C. Exercise induces rapid interstitial lung water accumulation in patients with chronic mountain sickness. Chest. 2012 Apr;141(4):953-8. Epub 2011 Sep 1.
Institute of Clinical Physiology, Pisa, Italy.

Abstract
BACKGROUND: Chronic mountain sickness (CMS) is a major public health problem in mountainous regions of the world. In its more advanced stages, exercise intolerance is often found, but the underlying mechanism is not known. Recent evidence indicates that exercise-induced pulmonary hypertension is markedly exaggerated in CMS. We speculated that this problem may cause pulmonary fluid accumulation and aggravate hypoxemia during exercise.
METHODS: We assessed extravascular lung water (chest ultrasonography), pulmonary artery pressure, and left ventricular function in 15 patients with CMS and 20 control subjects at rest and during exercise at 3,600 m.
RESULTS: Exercise at high altitude rapidly induced pulmonary interstitial fluid accumulation in all patients but one (14 of 15) with CMS and further aggravated the preexisting hypoxemia. In contrast, in healthy high-altitude dwellers exercise did not induce fluid accumulation in the majority of subjects (16 of 20) (P = .002 vs CMS) and did not alter arterial oxygenation. Exercise-induced pulmonary interstitial fluid accumulation and hypoxemia in patients with CMS was accompanied by a more than two times larger increase of pulmonary artery pressure than in control subjects (P < .001), but no evidence of left ventricular dysfunction. Oxygen inhalation markedly attenuated the exercise-induced pulmonary hypertension (P < .01) and interstitial fluid accumulation (P < .05) in patients with CMS but had no detectable effects in control subjects.
CONCLUSIONS: To our knowledge, these findings provide the first direct evidence that exercise induces rapid interstitial lung fluid accumulation and hypoxemia in patients with CMS that appear to be related to exaggerated pulmonary hypertension. We suggest that this problem contributes to exercise intolerance in patients with CMS. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT01182792; URL: www.clinicaltrials.gov.

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